Path 2

Legalize It: Another Approach to Winning Plan B

November 22, 2005

With conservative Republicans in charge, this Congress probably won’t be forcing the Food and Drug Administration to put the emergency contraceptive Plan B on pharmacy shelves. Advocates have already turned to another venue: the courts.

In January, hours after the FDA had ignored a deadline for ruling on over-the-counter sales of Plan B, the New York–based Center for Reproductive Rights sued in federal court. Filed by nine women and two reproductive-health groups, the lawsuit claims the agency “did not follow its own procedures or statutory mandates when it first denied the application.” And it accuses the FDA—specifically, former FDA commissioner Lester Crawford—of violating women’s constitutional rights to privacy and equal protection.

The plaintiffs are asking the judge to order the FDA to make Plan B available without a prescription to women of all ages.

According to the lawsuit, Crawford and FDA officials have not only ignored “sound science,” but have held Plan B to a “higher and different standard” than other over-the-counter drugs. The two claims echo findings made by the Government Accountability Office in its recent, high-profile report; indeed, the court papers draw on some of the same internal documents, such as memorandums from division chiefs to top FDA officials recommending approval.

“Our lawsuit shows that the FDA is breaking its own rules,” says Center for Reproductive rights staff attorney Nan Strauss. The Justice Department has been trying to get the suit thrown out, but Strauss and her colleagues think the GAO report will only bolster their case. A court proceeding is slated for December 20 at the U.S. Court for the Eastern District of New York.

Neither the lawsuit nor the GAO report comes out and says the FDA made a political decision on Plan B, but the inference is obvious.
As Strauss says, “It’s clear the agency wasn’t doing its job or taking science into account.”